A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement

ISRCTN ISRCTN58128724
DOI https://doi.org/10.1186/ISRCTN58128724
Secondary identifying numbers 7766
Submission date
24/06/2010
Registration date
24/06/2010
Last edited
01/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Sukumaran Nair
Scientific

Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Study information

Study designSingle-centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement
Study acronymMiniStern Trial
Study objectivesMiniStern is a pragmatic, prospective randomised controlled trial comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
Ethics approval(s)MREC approved (ref: 09/H0301/58)
Health condition(s) or problem(s) studiedTopic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery
InterventionComparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
Intervention typeProcedure/Surgery
Primary outcome measureTotal length of stay in hospital for the index AVR operation measured in days
Secondary outcome measures1. Fitness for discharge
2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG)
3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery
4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion
5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months
Overall study start date30/11/2009
Completion date01/09/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 240
Total final enrolment222
Key inclusion criteria1. Aged greater than 18 years at the time of surgery, either sex
2. Elective, first time, isolated aortic valve replacement (AVR)
Key exclusion criteria1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30%
2. Documented chest wall deformities
3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD)
4. Current body mass index (BMI) greater than 35 kg/m^2
5. Concomitant cardiac surgery
6. Redo surgery
7. Median sternotomy indicated
Date of first enrolment30/11/2009
Date of final enrolment01/09/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Papworth Hospital NHS Foundation Trust
Cambridge
CB23 3RE
United Kingdom

Sponsor information

Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom

Website http://www.papworthhospital.nhs.uk/index.php
ROR logo "ROR" https://ror.org/01qbebb31

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2018 01/10/2019 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

01/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.